ConforMIS Update on iTotal Hip FDA Submission

ConforMIS (CFMS) withdrew its FDA 510(k) application for the iTotal Hip device, and plans to submit a new application in 2H16.

CFMS submitted the application for the customized total hip replacement, as planned, in 2015. In light of an inability to address FDA's review questions within an allowed review timeframe, CFMS elected to withdraw the...

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Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.

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